Radium-223 treatment for prostate cancer with bone metastases
68Ga-PSMA-PET/CT and Genomic Alterations for Future Selection of Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) for Radium-223 Treatment.
This study is testing if Radium-223 treatment can help men with prostate cancer that has spread to their bones and whether certain scans and blood tests can predict how well the treatment works.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Locations | 5 sites (Amsterdam, North Holland and 4 other locations) |
| Trial ID | NCT06659926 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Radium-223, a radionuclide therapy, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have bone-only disease. Participants will receive standard treatment with Radium-223 while also undergoing 68Ga-PSMA-PET/CT scans to assess the presence of extraskeletal lesions. The study aims to evaluate the predictive value of these imaging results and the potential of circulating tumor DNA (ctDNA) as a biomarker for treatment response. Patients will be monitored throughout the treatment with questionnaires and imaging to determine the effectiveness of the therapy.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed adenocarcinoma of the prostate, experiencing progressive disease with bone metastases.
Not a fit: Patients with extra-skeletal metastases or a poor performance status (ECOG score >2) may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with mCRPC by providing insights into the predictive value of advanced imaging techniques.
How similar studies have performed: Previous studies have shown promise with Radium-223 therapy, but the use of 68Ga-PSMA-PET/CT for predictive assessment in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate. * Progressive disease after previous treatment defined as a rise in serum (Prostate Specific Antigen) PSA (PCWG3 criteria(22), see appendix 1) and/or progression on conventional imaging (PCWG3). * A positive bone scan (osteoblastic bone metastases), with at least two metastases. * Hemoglobin concentration \>10 g/dl (6.2 mmol/l) and thrombocytes \>100 109/I at baseline. * Each patient will need to (continue to) receive adequate bone protective agents (e.g. bisphosphonates) and androgen deprivation therapy (ADT) according to current clinical guidelines. Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance score \>2 * Life expectancy \< 6 months. * Detected extra-skeletal metastases or lymph node metastases (\>3 cm short axis) as identified by conventional imaging (ceCT thorax/abdomen)
Where this trial is running
Amsterdam, North Holland and 4 other locations
- Nki-Avl — Amsterdam, North Holland, Netherlands (Recruiting)
- Meander Medisch Centrum — Amersfoort, Utrecht, Netherlands (Recruiting)
- Sint Antonius ziekenhuis — Nieuwegein, Utrecht, Netherlands (Recruiting)
- Diakonessenhuis — Utrecht, Netherlands (Not_yet_recruiting)
- Umc — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: J.C. van der Mijn — NKI-AvL
- Study coordinator: J.C. van der Mijn, Dr.
- Email: k.vd.mijn@nki.nl
- Phone: +31205129111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.